TPLC - Total Product Life Cycle

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Device	prosthesis, elbow, semi-constrained, cemented
Regulation Description	Elbow joint metal/polymer semi-constrained cemented prosthesis.
Product Code	JDB
Regulation Number	888.3160
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	153	158
Osseointegration Problem	61	69
Unstable	40	49
Loosening of Implant Not Related to Bone-Ingrowth	36	36
Fracture	25	25
Device Dislodged or Dislocated	22	41
Break	20	20
Loss of Osseointegration	13	13
Insufficient Information	12	12
Patient Device Interaction Problem	11	11
Naturally Worn	7	7
Appropriate Term/Code Not Available	6	7
Use of Device Problem	4	4
Detachment of Device or Device Component	4	4
Migration	4	4
Unintended Movement	3	3
Loss of or Failure to Bond	3	3
Migration or Expulsion of Device	2	2
Malposition of Device	2	2
Therapeutic or Diagnostic Output Failure	2	3
No Apparent Adverse Event	2	2
Inaccurate Information	2	2
Device Slipped	1	1
Mechanical Problem	1	1
Material Erosion	1	1
Material Integrity Problem	1	1
Degraded	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	80	84
Inadequate Osseointegration	64	72
Joint Laxity	47	56
Implant Pain	37	37
Bone Fracture(s)	37	38
Loss of Range of Motion	36	36
Failure of Implant	35	35
Insufficient Information	31	49
Pain	30	30
Swelling/ Edema	17	17
No Information	15	15
Osteolysis	12	12
Discomfort	11	11
No Clinical Signs, Symptoms or Conditions	11	11
Joint Dislocation	10	10
No Code Available	9	9
Injury	7	7
Limb Fracture	6	6
Fall	5	5
Abscess	5	5
Metal Related Pathology	4	4
No Known Impact Or Consequence To Patient	4	4
Ossification	4	4
Post Operative Wound Infection	4	4
Bacterial Infection	4	4
Fluid Discharge	4	4
Inadequate Pain Relief	4	4
Skin Inflammation/ Irritation	3	3
Sepsis	3	3
Inflammation	3	3
Tissue Damage	3	3
Foreign Body In Patient	3	3
Fever	3	3
No Consequences Or Impact To Patient	2	2
Cyst(s)	2	2
Post Traumatic Wound Infection	2	2
Neuropathy	2	2
Reaction	2	2
Erosion	1	1
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1
Scar Tissue	1	1
Foreign Body Reaction	1	1
Adhesion(s)	1	1
Rheumatoid Arthritis	1	1
Wound Dehiscence	1	1
Impaired Healing	1	1
Patient Problem/Medical Problem	1	2